Meta-analysis of the value of the procalcitonin test for the diagnosis of neonatal sepsis

Objective To evaluate the value of the procalcitonin(PCT)test for diagnosing neonatal sepsis.Methods A search in Cochrane Library,PubMed,Ovid,Springer,China National Knowledge Infrastructure(CNKI),Wanfang Chinese Periodical Database and Chinese Bio-medicine Database(CBM)was performed to identify relevant articles from Januanary 1990 to October 2009.The language of the researches wasn't limited.All non-English and non-Chinese articles were translated into Chinese to assess.Inclusion criteria were established based on validity criteria for diagnostic research.Subsequently,the characteristics of the included articles including study background,design information and diagnostic parameters were extracted.Statistical analysis was performed by employing Meta-DiSc 1.4 and SPSS 12.0 software.Heterogeneity of the included articles was tested for selecting proper effect model to calculate pooled weighted sensitivity,specificity and 95%CI.Summary receiver operating characteristic(SROC)curve was made and the area under the curve(AUC)and Q index was calculated.Finally,sensitivity analysis and comparison of sensitivity among different groups were performed.Results We searched 446 relevant English articles,98 Chinese articles and 21 other language articles.Thirty-three articles(18 English articles,11 Chinese articles and 4 other language articles)were included,with total 3 599 newborns.Three articles meeting inclusion criteria were analyzed for the value of the PCT test for the diagnosis of clinical early onset neonatal sepsis(EONS)in umbilical cord blood at birth,the pooled sensitivity,specificity and SROC AUC were 77.7%,82.8% and 0.833 7,respectively.Eight articles meeting inclusion criteria were analyzed for the value of serum PCT levels for the diagnosis of clinical EONS within 0-12 h after birth,the pooled sensitivity,specificity and SROC AUC were 76.7%,87.1% and 0.896 5,respectively.Four articles meeting inclusion criteria were analyzed for the value of serum PCT levels for the diagnosis of clinical EONS within 12-24 h after birth,the pooled sensitivity,specificity and SROC AUC were 76.6%,88.5% and 0.884 4,respectively.Six articles meeting inclusion criteria were analyzed for the value of serum PCT levels for diagnosis of clinical EONS within 24-48 h after birth,the pooled sensitivity,specificity and SROC AUC were 69.8%,88.2% and 0.894 7,respectively.Fifteen articles meeting inclusion criteria were analyzed for the value of serum PCT levels for the diagnosis of clinical late onset neonatal sepsis(LONS),the pooled sensitivity,specificity and SROC AUC were 79.0%,92.3% and 0.963 2,respectively.Fifteen articles meeting inclusion criteria were analyzed for the value of serum PCT levels for the diagnosis of proven LONS,the pooled sensitivity,specificity and SROC AUC were 84.5%,80.9% and 0.934 5,respectively.Significant heterogeneity among studies was observed.Sensitivity analysis showed that differences in PCT assay producer and PCT cutoff,study countries,gestational age and severity of sepsis in the study population may partially explain the between-studies heterogeneity.Conclusions The PCT test showed good accuracy in diagnosing neonatal sepsis,regardless of differences in diagnostic criteria or time points for testing.PCT should be combined with other diagnostic markers to further improve the sensitivity and accuracy in the diagnosis of sepsis.